RCT. Two substudies (clinical and experimental). Main objective of the trial is to examine if oxytocin, compared to placebo shows any additional effect on the therapy achievements (outcome) of patients with borderline personality disorder, who receive an in-patient standard psychotherapy (Dialectical-behavioral-therapy, Marsha Linehan (2006)).

Secondary objectives :

Investigate if oxytocin compared to placebo enhances social trust and emotion recognition in patients with borderline personality disorder. Comparison of the effects of Oxytocin on patients with BPD and major depression.

Further study details as provided by Prof. Dr. Markus Heinrichs, University of Freiburg:

Primary Outcome Measures:

BPD Symptoms [ Time Frame: BPD Symptoms ]

Estimated Enrollment:

150

Study Start Date:

January 2011

Estimated Study Completion Date:

January 2016

Primary Completion Date:

August 2014 (Final data collection date for primary outcome measure)

Intervention Details:

Drug: Oxytocin

Oxytocin

Eligibility

Ages Eligible for Study:

18 Years to 50 Years (Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Gender: Both, male and female

Minimum Age: 18 Years

Maximum Age: 50 Years

Borderline personality disorder or major depression (clinical control group)

Mini Mental Status Test > 27 (capacity to consent)

Exclusion Criteria:

chronic or acute somatic health problems

Schizophrenia

Bipolar affective disorder

pregnancy

breast feeding

neurological disorder

allergy to antidegradants

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01243658